Fastgen Corporation

Cardiac-1 Rapid Test

Troponin I

INTENDED USE:   The Cardiac-1 Rapid Test is intended for the in vitro diagnostic use in the qualitative  detection  of cardiac Troponin I in human serum, plasma, or whole blood samples.

 

Features and Advantages of Cardiac-1 Rapid Test

  • Highly sensitive chromatographic immunoassay

  • US FDA 510(K) approved test

  • Specific detection of cardiac Troponin I, the current gold standard biochemical indicator for acute myocardial infarction (AMI)

  • Rapid test format delivers results in minutes

  • Strong prognostic value in unstable angina

 Advantages of cardiac Troponin I as a cardiac Marker

  • More sensitive and specific indicator of AMI than CK-MB

  • Allows timely triage of chest pain patients into appropriate treatement and risk categories

  • Levels elevated for 5-7 days, providing a longer diagnostic window

  • Strong Prognostic value in unstable angina

Potential Utilities in the following Clinical Presentations

  • Chest pain with nondiagnostic ECG

    • elevation in Troponin I specific indicator for acute myocardial infarction (AMI)

    • negative assay results in sequential testing may allow rule-out of infarction

  • Chest pain, abnormal ECG with creatine kinase (CK) elevation following trauma or surgery

    • cardiac Troponin I helps differentiate true or false positive for myocardial cell damage

  • Persistent Chest pain prior to office/hospital presentation

    • prolonged elevation renders Troponin I sensitive indicator of AMI for up to 7 days

  • Decompensated heart failure, acute myocarditis, hypotension, syncope or prolonged

    • tachyarrhythmia

    • Troponin I assay able to detect small amounts of myocardial necrosis

Performance Characteristics

  • Cut-off positivity concentrations-1.5 ng/ml free Troponin I or 5 ng/ml ternary complex

  • Excellent correlation with commercially available ELISA assay:

Fasgen

Troponin I

Rapid Test

Troponin I ELISA Test

≥ 1.5 ng/ml

≤ 1.5 ng/ml
+ 149 4
- 1 146
Total 150 150

Sensitivity                               149/150 = 99.3%

Specificity                               146/150 = 97.3%

Overall Accuracy                   295/300 = 98.3%

 

- 100% agreement between protocols using whole blood samples and “homologous” plasma isolated

 References:

Cummins, B., Auckland, M.L., and Cummins, P., Am. Heart J.,113:1333-1344 (1987)

Larue, C. et. al., Clin. Chem.,39:972 (1993)

Adams, III, J.E. et. al., Clin. Chem., 40:1291 (1994)

Mair, J. et. al., Lancet 341:838-839 (1993)

Antman, E.M. et. al., N. Engl. J. Med., 335:1342-1349 (1996)

Myocardial Infarction redefined—a consensus document of the Joint European society of cardiology/American College of Cardiology Committee for the re-definition of myocardial infarction.  Eur. Heart J., 21:1502 and J. Am. Coll. Cardiol., 36:959 (2000)

Product Information 

 in Acrobat (PDF)

 

Product Information 

 in Acrobat (PDF)

 

 

To Order

Catalog No. FGD0001    For use with serum samples

Catalog No. FGD0002    For use with whole blood, plasma, or serum samples

Not available for sale in the US

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